Pharmaceutical Manufacturing, Scale Up and Tech transfer

Recently, process engineers have shown inclination to single-use, modular and continuous manufacturing technologies to improve efficiency and minimize scale-up and technology transfer challenges in the pharmaceutical industry. Lot of these innovations are driven by updates instigated by the FDA. The changes are inevitable; especially in the already aging biopharmaceutical sector of the industry, where original processes are often overly complex, and are characterized by inefficiency, and occasionally, inherent unpredictability.

 

  • Challenges in pharma manufacturing
  • ICH Q10
  • Knowledge transition between development and manufacturing sites
  • Tech transfer protocols and guidelines
  • Tech transfer key considerations
  • Challenges in tech transfer

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